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HYTN Innovations Inc. has received a Cannabis Drug Licence (CDL) from Health Canada, allowing them to manufacture cannabis-derived pharmaceutical drugs. This license, along with their existing certifications, positions HYTN to expand into pharmaceutical drug development, support clinical research, and pursue global market authorizations. The company can now serve both the regulated cannabis and pharmaceutical markets, acting as a Contract Development and Manufacturing Organization (CDMO) for biotech and pharmaceutical companies. The global pharmaceutical industry is increasingly integrating cannabinoids, as seen with Epidiolex's significant sales, highlighting the commercial viability of cannabinoid-based pharmaceuticals. The CDL enables HYTN to address the limited access to GMP-compliant, cannabis-derived active pharmaceutical ingredients (APIs) and finished drug products, supporting various pharmaceutical needs worldwide.

HYTN Secures Canadian Cannabis Drug License

Jul 15, 2025

Mg Magazine Newswire

MG Magazine



*VANCOUVER, British Columbia* — HYTN Innovations Inc., a leader in
pharmaceutical-grade cannabis manufacturing, received a Cannabis Drug
Licence (CDL) from Health Canada. The CDL, issued July 2, complements
HYTN’s existing Drug Establishment Licence (DEL) and federally issued
Cannabis Licences, placing the Company among a limited group of
organizations authorized to manufacture cannabis-derived pharmaceutical
drugs in Canada.

As an existing Good Manufacturing Practices (GMP)-certified manufacturer,
HYTN serves international markets with cannabinoid products under
GMP-cannabis frameworks. The newly issued CDL provides new and distinct
regulatory pathways to the Company, enabling the fabrication, packaging,
labelling, and distribution of prescription pharmaceutical products (Rx).
This advancement permits HYTN to support clinical research, generate
regulatory data, and pursue future drug approvals and market authorisations.

“Securing the CDL is an important milestone in HYTN’s evolution,” said
Jason Broome, Chief Operations Officer of HYTN. “This achievement enhances
our capabilities, allowing us to strategically expand beyond GMP-cannabis
frameworks and participate directly in pharmaceutical drug development.”

With the CDL in place, HYTN has expanded its capabilities to serve both the
regulated cannabis market and the regulated pharmaceutical market,
supported by the following strategic advantages:

Export-Ready GMP-Certified Manufacturing: HYTN operates under a DEL for
non-sterile pharmaceuticals and is compliant with international GMP
standards recognized by the United Kingdom, European Union and Australia.

Prescription Drug Development Pathway: With the CDL in place, HYTN can
begin developing cannabis-derived drug products. This opens the door to
submissions for Marketing Authorisations worldwide.

EudraGMDP Registration in Progress: HYTN, in conjunction with European
partners, is progressing with its EudraGMDP registration, which, if
granted, would enable the Company to be listed as an approved active
pharmaceutical ingredient (API) and drug product manufacturer within
European pharmaceutical databases.

Contract Development and Manufacturing Organization (CDMO) & Clinical
Support: HYTN’s dual licensing enables it to act as a CDMO partner for
clinical-stage biotech and pharmaceutical companies, providing
GMP-compliant cannabinoid production, formulation development, and product
release within a regulated drug framework.

The global pharmaceutical industry is integrating cannabinoids as APIs.
Epidiolex, an FDA- and EMA-approved prescription drug derived from
cannabidiol (CBD), is authorized for the treatment of severe seizure
disorders including Lennox–Gastaut syndrome, Dravet syndrome, and tuberous
sclerosis complex. According to its parent company, Jazz Pharmaceuticals,
Epidiolex generated net product sales of USD $972.4 million in 2024, with a
reported gross margin of 88.2% of net product sales, underscoring the
clinical utility and commercial viability of cannabinoid-based
pharmaceuticals.

Despite these advancements, access to GMP-compliant, cannabis-derived APIs
and finished drug products remains limited, due in part to the high
regulatory and operational standards required to serve the pharmaceutical
supply chain.

With the recent issuance of its CDL, HYTN joins a small group of global
manufacturers equipped to support:

- Clinical-stage pharmaceutical sponsors and biotech companies seeking
GMP cannabinoid inputs.
- Distributors and pharmacies in Europe, the UK, and Australia operating
under prescription-only frameworks.
- Special access, named patient, and compassionate use programs
requiring pharmaceutical-grade supply.
- Government tenders and public health initiatives focused on regulated
cannabinoid therapies.

This expanded regulatory scope enables HYTN to participate in the global
supply chain for cannabinoid-based therapeutics through internationally
compliant manufacturing and strategic pharmaceutical partnerships.
About HYTN Innovations Inc.

HYTN Innovations Inc. is a pharmaceutical company specializing in the
formulation, manufacturing, marketing, and sale of products containing
psychoactive and psychotropic compounds, including cannabis-derived
cannabinoids and psilocybe-derived tryptamines. HYTN is dedicated to
becoming a premier provider of these products across all federally
regulated markets. The Company accomplishes this by strategically
identifying market opportunities and bringing products to market through
its advanced development platform.
About Cannabis Drug Licenses (CDL)

A CDL is issued by Health Canada under the Food and Drug Regulations and
authorizes the possession, production, packaging, labelling, and
distribution of cannabis when used as an active ingredient in
pharmaceutical drug products. The CDL is required for any company intending
to manufacture prescription drugs containing cannabis for human use. It can
only be obtained by holders of a DEL and must meet the same regulatory
standards applied to conventional pharmaceutical manufacturers, including
compliance with GMP
About Good Manufacturing Practices (GMP)

GMP guidelines provide guidance for manufacturing, testing, and quality
assurance to ensure that a manufactured product is safe for human
consumption or use. Many countries have legislated that manufacturers
follow GMP procedures and create their own GMP guidelines that correspond
with their legislation.

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